Condition category
Oral Health
Date applied
29/07/2020
Date assigned
20/08/2020
Last edited
12/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to evaluate the safety and tooth whitening effect of a tooth whitening patch with primer.

Who can participate?
Adults over 20 years of age with tooth discolouration

What does the study involve?
The effectiveness of whitening is confirmed by attaching a tooth whitening patch with primer for 30 minutes for 10 days. Safety is checked by examining the presence or absence of side effects caused by whitening through questionnaires and oral examinations.

What are the possible benefits and risks of participating?
Possible benefits include effective tooth whitening. Possible risks include gingival (gum) irritation and tooth tingling.

Where is the study run from?
Kyungpook National University (South Korea)

When is the study starting and how long is it expected to run for?
January 2019 to October 2019

Who is funding the study?
LG Household & Health Care Research Park (South Korea)

Who is the main contact?
Jin-kyoung Kim
jkk0621@dhc.ac.kr

Trial website

Contact information

Type

Public

Primary contact

Miss Jinkyoung Kim

ORCID ID

Contact details

Department of Preventive Dentistry
School of Dentistry
Kyungpook National University
2177
Dalgubeol-daero
Jung-gu
Daegu
41940
Korea
South
+82 (0)53 660 6875
jkk0621@dhc.ac.kr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

KCT0004625

Study information

Scientific title

Clinical efficacy of bleaching patch with primer in randomized controlled trial

Acronym

CEPT

Study hypothesis

To clinically evaluate the efficacy and safety of the primer that contains taurine and self-bleaching patches containing 3.0% hydrogen peroxide.

Ethics approval

Approved 11/03/2019, Kyungpook National University Bioethics Review Committee (Department of preventive Dentistry School of Dentistry, Kyungpook National University 2177 Dalgubeol-daero, Jung-gu, Daegu 41940, Korea; +82 (0)53 2000 5430; knuiars@knu.ac.kr), ref: KNU 2019-0009

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not applicable

Condition

Tooth whitening

Intervention

This is a double-blinded randomized clinical trial that referred to the Consolidated Standards of Reporting Trials (CONSORT) 2010 guideline from design to completion.

Healthy adult applicants interested in tooth whitening are recruited through snowball sampling. The effectiveness of whitening is confirmed by attaching a patch containing 3.0% peroxide and a primer containing a mitigating component for 30 minutes for 10 days. In addition, safety is checked by examining the presence or absence of side effects caused by whitening through self-filling questionnaires and oral examinations.

When applied for at least 30 minutes with a self-whitening patch containing 3.0% peroxide, the efficacy of whitening compared to the placebo-controlled group is confirmed, and the difference between application times of 30 minutes is confirmed.

After applying the taurine-containing primer, a self-administered questionnaire completed asking about the patient's subjective symptoms and an oral examination is carried out for the side effects of whitening to confirm the clinical safety.

Total duration of intervention and follow-up: 18/03/2019 to 26/04/2019.

Intervention type

Drug

Phase

Not Applicable

Drug names

Hydrogen peroxide

Primary outcome measure

Tooth color measured using ∆L, ∆a, ∆b with Shade Eye NCC and Vita classical shade guide at baseline, 3, 5, 7 and 10 days

Secondary outcome measures

Side effects measured using questionnaire, VAS scale and oral examination before patching and after 3, 5, 7 and 10 days

Overall trial start date

14/01/2019

Overall trial end date

31/10/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adults over 20 years of age who agree to take the test
2. People with good general health and oral health
3. A person with six maxillary anterior teeth
4. A person with similar level of discoloration of each tooth showing proper tooth discoloration
5. A person who understands the purpose of the test and is able to read and write
6. Who can follow the test procedure and follow the visit schedule
7. Persons who can follow up during the test

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

56

Total final enrolment

55

Participant exclusion criteria

1. People with inadequate dentition in the practice of tooth whitening
2. People with resin and porcelain restorations in the anterior region
3. A person who shows signs of inflammation in teeth due to dental caries or dental erosion
4. People with hypersensitivity due to gingivitis and periodontitis
5. People with excessive discolouration due to drugs and congenital anomalies
6. Those who have experienced tooth whitening in the past and have not passed 3 years
7. Women who are pregnant, breastfeeding or have a pregnancy plan during the test
8. Other diseases that may affect the efficacy and safety evaluation of the drug
9. A person who is taking or administering medication
10. People participating in other clinical trials or human attachment tests
11. Anyone who can not communicate or follow instructions
12. Those who do not qualify for the test under the judgment of the other examiners

Recruitment start date

01/03/2019

Recruitment end date

29/03/2019

Locations

Countries of recruitment

Korea, South

Trial participating centre

Kyungpook National University
Department of Preventive Dentistry School of Dentistry 2177, Dalgubeol-daero, Jung-gu
Daegu
41940
Korea, South

Trial participating centre

Daegu Health University
Department of Dental Hygiene 15, Youngsong-ro, Buk-gu
Daegu
41453
Korea, South

Trial participating centre

Busan Public Health Policy Institute
359 World Cup-daero Geoje 2(i)-dong Yeonje-gu
Busan
-
Korea, South

Trial participating centre

Kyungpook National University
Department of Conservative Dentistry, School of Dentistry 2177, Dalgubeol-daero, Jung-gu
Daegu
41940
Korea, South

Trial participating centre

LG Household & Health Care Research Park
-
Seoul
-
Korea, South

Sponsor information

Organisation

Kyungpook National University

Sponsor details

Department of Preventive Dentistry
School of Dentistry
Daegu
41940
Korea
South
+82 (0)53 660 6875
jkk0621@dhc.ac.kr

Sponsor type

University/education

Website

http://www.knu.ac.kr/wbbs/

Funders

Funder type

Industry

Funder name

LG Household & Health Care Research Park

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

08/09/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/08/2020: Trial's existence confirmed by Kyungpook National University Bioethics Review Committee.